The problem of soothing and pacifying restless, distressed, crying, and often termed colicky infants, has been with the human race since early times. It has long been practiced to impart vibrational rhythmic repetitory motion to the infant in an effort to sooth and pacify. Success is often dependent on unknown factors, has not been predictable, and may be exasperatingly unobtainable in particular circumstances.
This has been a source of frustration to the parents, and those others in attendance, as well as the pain distress to the infants.
These problems have attracted the attention of previous inventors and many authors. A typical example of a prior art patent is U.S. Pat. No. 3,311,935--Petty, which discloses a vibration imparting device for attachment beneath a crib/bed for infants. A frequency of about three hundred and fifty RPM (5.83 cycles per second) is stated to be satisfactory.
U.S. Pat. No. 2,932,821--Horton, discloses an infant pacifying device which emits a audible buzzing sound accompanied by a mild vibratory effect such as are encountered by the operation of an electric shaver or the like.
U.S. Pat. No. 3,799,154--Knop, reveals a device for insertion under the mattress of a bed that imparts vibration thereto. The patent is directed primarily to adult massage. An eccentric weight is rotated to provide cyclic oscillation or displacement.
U.S. Pat. No. 3,872,526--Betts, shows a vibratory waterbed providing specified non critical frequencies of between ten and eighteen hundred cycles per second. Because of the fluid nature of a waterbed, amplitude would vary from place to place and would be uncontrollable.
U.S. Pat. No. 3,503,389--McKee et al., discloses a vibration inducing apparatus for placement between the frame and boxsprings of a bed with a teaching that the vibrations are between three hundred and fifty and one thousand RPM, (which is equivalent to between 5.8 and 16.7 cycles per second).
U.S. Pat. No. 3,035,572--Houghtaling, discloses a vibrator attached beneath the springs of a bed, couch, or cushion. The Patentee shows no specific teaching concerning vibratory frequency or amplitude and any connection thereto with therapeutic results.
U.S. Pat. No. 3,019,785--Eiden, reveals a vibratory massage cushion having eccentrically weighted rotating motors to produce an oscillating effect to an elongated member that is intended to slide between a mattress and bedspring or other support means. There is no teaching of critical amplitude and the emphasis is on message. Sound is not a teaching in this patent.
An article published in The Journal of Psychology, 1971, 78, 269-276 by Leland D. Van Den Daele entitled "Infant Reactivity to Redundant Proprioceptive and Auditory Stimulation: A Twin Study"--discusses the activity of infants under the influence of motion and sound. The activity was conducted with a "displacement of three inches at either thirty or sixty cycles per minute" (emphasis added) and an eighty decibel (DB sound) thirty inches away from the subjects. The displacement disclosed is a "rockerbox", being intended to imitate the normal material head to toe rocking action.
U.S. Pat. No. 2,512,621--Emerson, discloses a vibrator panel comprising a thin stiffly resilient panel which is operated at an amplitude ("eccentricity") of the order of five sixteenths of an inch.
Even though there have been patented approaches to the problems and fussiness in young infants, the symptom of colic remains one of the most common encountered in pediatric practice today. Much has been written in the literature on this subject including the references listed further in this specification.
Although colic is difficult to define, it is perceived as an unexplained paroxysms of irratability, fussing, crying and often sustained screaming accompanied by indication of colinic peristalsis. The symptoms usually start after feeding, and they may occur in regular twenty-four hour cycles that are quite predictable. Symptoms are reported to be worst late in the day.
The pediatric text authored by Kempe, Silver, and O'Bryen (1978), presents a typical description:
"Colic or paroxysmal fussing is a common problem in young infants. It is most common in the evening. It may build up in crescendo, with the baby drawing his legs up onto his abdomen, and is frequently relieved by the passage of flatus. This period usually begins at age 2-3 weeks and disappears by 10-12 weeks--so called `3-month colic`. The course is not clear, but `developmental colic` may be related to overready response to stimulation, irregular gastrointestinal peristalis, and other as yet unintegrated autonomic functions characteristic of the first 2-3 months." (p. 55)
The incidents in the general population of newborn to three month old infants is reported at nine to twenty-three percent. In low birthweight infants colic occurs at 11.4 percent of the population. With 3.6 million babies born in the United States each year this represents a significant number of affected infants.
It has been known as a treatment that rhythmic rocking motion or rocking vibration has a soothing effect on fussiness and distress in infants. Recommendations on easing colicky episodes in infants by rocking or rhythmic motion are found in pediatric texts. However, such recommendations have been generalized.
It is an object of this invention to provide specific ranges of motion frequency and amplitudes, as well as sound for the soothing and pacification of infants who are diagnosed as having colic and as a corollary, to provide comfort to infants during spells of fussiness and crying in general.
The advantages from the treatment of colic by vibratory motions and/or sound are clear. Mild well-timed periods of stimulation have no known ill effects, and when effective in easing the infant's distress, may decrease the need of drugs such as phenobarbital, bentyl, etc. In addition to the concern about harmful effects of drugs, there is serious doubt that conventional drug therapy is effective. The possibility of drug tampering is circumvented by the none invasive treatment with this medical device. In addition to easing the infant's pain and discomfort, providing rhythmic motion and sound to soothe the infants eases the strain on parents, decreasing the amount of child abuse associated with colic and increasing the likelihood of improving the quality of the mother-infant relationship. As well, there are reports of parents using potentially dangerous home remedies in their attempt to comfort the distressed infant. With a product and process that provides safe treatment for the symptoms of colic available to parents, there may be fewer ill advised attempts to ease the infants discomfort.
Demographic studies show 3.73 million babies born in the USA in 1982 projecting up to 3.99 million by 1986 and tapering down to 3.55 million by the year 1992.
Taking into consideration the incidence of colic ranging from nine to twenty-three percent, the affected population today ranges from three hundred thirty-six thousand to eight hundred fifty-seven thousand colicky babies. In 1986 it will peak at a range of three hundred sixty thousand to nine hundred seventeen thousand colicky babies. Thus it will be seen that there is a strong need for a medical device and process which will ease the discomfort of fussy and colicky infants with significant and predictable degrees of success without the use of drugs with questionable long term effects.
Predictably effective motion and/or sound simulation thus has the object of (a) easing infant pain and discomfort; (b) decreasing the use of drugs; (c) enhancing the quality of parent/infant relationship; and (d) decreasing the incidence of child abuse associated with paternal frustration or the administration of potentially dangerous home remedies.